|
Street Talk: CEO Paychecks: How They Are Determined
|
|
|
| By
Brian O'Connell
|
|
|
|
In the September 2006 issue I wrote about the ticklish issue of CEO pay and how shareholder groups, especially the powerful pension and other institutional groups, are growing sick and tired of CEO overpayment and underperformance.
|
|
|
|
China Today: Pharmaceutical Distribution in China
|
|
|
| By
Eliza Yibing Zhou
|
|
|
|
China today represents a $15-billion market for pharmaceutical products. China's pharmaceutical industry has been expanding at about 20% over the past five years. It has been predicted that China will become the world's fifth largest single pharmaceutical market by 2010. With such a fast-growing market segment and a huge population, simply getting pharmaceuticals to the patients and healthcare providers is becoming a daunting task. Biopharmaceuticals distributers face the same challenge, with the added complications associated with cold-chain management, shelf-life, and product stability.
|
|
|
|
From the Editor: Cloning and Biotech Progress
|
|
|
| By
Laura Bush
|
|
|
|
The recent FDA decision that meat from cloned animals is safe for human consumption seems logical enough. A protein is a protein. But even if we can eat such meat, it doesn't necessarily make economic or ecological sense to do so.
|
|
|
|
Final Word: Should You Need FDA Approval to Make Manufacturing Changes?
|
|
|
| By
John T. English
|
|
|
|
The pharmaceutical industry is well aware that FDA is trying to take a risk-based approach to enforcing the current good manufacturing practices (cGMP) regulations. This approach is driven by an economic reality: FDA simply does not have the resources to inspect every facility every other year. The organization doesn't even have the resources to inspect facilities every three years. Likewise, it is not cost-effective for our companies to carry out a complete, documentation-oriented revalidation for every process change, regardless of its significance or risk.
|
|
|
|
Regulatory Beat: Quality Standards to Reshape Manufacturing
|
|
|
| By
Jill Wechsler
|
|
|
|
A series of ICH guidances are encouraging industry to adopt quality-based approaches for achieving the "desired state" of drug and biotech manufacturing: more efficient and flexible operations that can reliably produce high quality therapies with less regulatory oversight.
|
|
|
